31. Court Limits Access To Experimental Drugs

It may seem like simple compassion to give the terminally ill access to experimental drugs not yet approved by the FDA, but some argue it may also jeopardize the effectiveness of clinical trials and leave patients open to exploitation. In August, the U.S. Court of Appeals for the District of Columbia upheld (pdf) the power of the FDA to control patients’ access to unapproved drugs. The court stated that patients do not have a fundamental right to drugs that have not been proven safe.

The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation had filed the suit against the FDA. “What we argue in our lawsuit is that the decision should be a patient’s with their doctor,” says Frank Burroughs of the Abigail Alliance. He founded the organization in 2001 after his 21-year-old daughter Abigail died from head and neck cancer. She had been denied access to the experimental drug Erbitux, which was later approved by the FDA. Burroughs says the groups are planning an appeal to the U.S. Supreme Court.

Many legal experts and ethicists argue that access to unapproved drugs would undermine the scientific process that determines which drugs are effective as well as the FDA’s ability to determine drug safety. Only 8 percent of cancer drugs that enter clinical trials earn FDA approval. The bulk are rejected as ineffective or unsafe. “The very, very sick are open to exploitation,” says Arthur Caplan, chairman of medical ethics at the University of Pennsylvania. He also notes that patients may not join clinical trials if they can get the drugs otherwise, which could impair the development of new drugs.

“I think the court got it right,” says Peter Jacobson of the ­University of Michigan School of Public Health. Jacobson views the FDA’s efforts to extend the compassionate use policy as the better way to handle the issue. “Then you’re able to distribute some of these drugs under some kind of scientific protocol without compromising clinical trials that are needed for long-term ­understanding.”